Z-0878-2021Class II

Synapse PACS Software Versions 5.1 and higher

Name: Z-0878-2021 Synapse PACS Software Versions 5.1 and higher
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2020-09-11
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2020-09-11 / Open, Classified / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Synapse PACS Software Versions 5.1 and higher on 2020-09-11. FDA classified it as Class II and gives the reason as "There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0878-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-11
Posted: 2021-01-17
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse PACS Software Versions 5.1 and higher
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Root cause tag: design
FDA root cause: Device Design
Action: Letter was sent to all affected customers on 09/11/2020 stating the following: There have been no reported patient injuries associated with these issues. In an effort to ensure the highest level of customer satisfaction, FUJIFILM will offer an upgrade to Synapse PACS 5.7.200US to resolve these issues. Until your upgrade is scheduled and completed, you can continue to safely use Synapse PACS by following these additional instructions: 1. When selecting a patient off the PowerJacket or work list, please ensure that the patient information displayed in the viewer matches the desired patient and matches the PowerJacket. 2. If using a Siemens Modality, Max SUVs should not be used when rendering a clinical decision until the issue is corrected. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken.
Quantity in commerce: 235
Distribution: Software was distributed to medical facilities nationwide throughout the U.S.
Product codes and lots: Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0878-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0878-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-27	2021-01-16

Product code LLZ

K160108Class IISynapse PACSFujifilm Medical Systems U.S.A, Inc. / cleared 2016-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)